Neuron Therapeutics, Inc., 14-GAUGE Lumbar Puncture Set, Model PN1000735

Q: What is the product code of K021196?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.

FDA 510(k) K021196 · Neuron Therapeutics, Inc.

Substantially Equivalent

510(k) numberK021196

Submission

Device name: Neuron Therapeutics, Inc., 14-GAUGE Lumbar Puncture Set, Model PN1000735
Applicant: Neuron Therapeutics, Inc.
Malvern, PA, US
Received: April 16, 2002
Decision date: July 1, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: JXG – Shunt, Central Nervous System And Components
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5550
Specialty: Neurology
Implant: Yes

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Questions and answers

When was Neuron Therapeutics, Inc., 14-GAUGE Lumbar Puncture Set, Model PN1000735 cleared by the FDA?

Neuron Therapeutics, Inc., 14-GAUGE Lumbar Puncture Set, Model PN1000735 (K021196) received a 510(k) decision of Substantially Equivalent on July 1, 2002, 76 days after the submission was received.

What is the product code of K021196?

The FDA product code is JXG – Shunt, Central Nervous System And Components, a Class II (moderate risk) device regulated under 21 CFR 882.5550.